Endoscopic suture cinch

ABSTRACT

A method cinches a suture. The method provides a cinch having a suture capturing portion configured to capture a suture, a cinch lock coupled with the suture capturing portion, and a cinch anchor having a lumen. The suture capturing portion is extended out of the lumen to capture the suture. The suture is captured by the suture capturing portion. The suture capturing portion is retracted into the lumen of the cinch anchor. The suture is cinched between the cinch lock and the cinch anchor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation-in-part of U.S. patentapplication Ser. No. 17/508,989, filed Oct. 23, 2021, entitled“ENDOSCOPIC SUTURE CINCH,” which claims priority to provisional U.S.patent application No. 63/104,585, filed Oct. 23, 2020, entitled“ENDOSCOPIC SUTURE CINCH AND METHOD OF APPLYING,” the disclosures ofwhich are each incorporated herein, in their entirety, by reference.

This patent application also claims priority to provisional U.S. patentapplication No. 63/399,078, filed Aug. 18, 2022, entitled “ENDOSCOPICSUTURE CINCH,” the disclosure of which is incorporated herein, in itsentirety, by reference.

STATEMENT AS TO FEDERALLY SPONSORED RESEARCH

This invention was made with government support under Award #1912944 byNational Science Fund (NSF) SBIR Phase I. The government has certainrights in the invention.

FIELD OF THE INVENTION

Illustrative embodiments of the invention generally relate to endoscopicdevices and, more particularly, the various embodiments of the inventionrelate to a suture cinch that is delivered through a working channel ofthe endoscope.

BACKGROUND OF THE INVENTION

A suture cinch is an alternative method to tying a knot to secure andanchor the suture for wound closure and tissue approximation. The cinchcan be utilized for both interrupted and running stitches. Such cinchingdevices generally affix the suture by compression between two concentriccylindrical components. Currently available flexible endoscopy cinchingdevices load the suture into the cinch outside the patient's body. Afree end of the suture (which is the end of the suture not attached to aneedle) must be loaded into a cinching device outside the endoscope'sworking channel. Such devices often utilize a suture threader to threadthe suture into a cinch, enabling the cinch to advance through a workingchannel of the endoscope.

Endoscopic snares usually are used to remove a polyp, adenoma, orforeign body from inside gastrointestinal tract through working channelof an endoscope. Alternatively, endoscopic hooks are currently used forendoscopic submucosal dissection.

SUMMARY OF VARIOUS EMBODIMENTS

In accordance with one embodiment of the invention, a method cinches asuture. The method provides a cinch lock comprising a suture capturingportion configured to capture a suture. The suture capturing portionextends out of a lumen of a cinch anchor to capture the suture. Thesuture capturing portion is retracted into the lumen of the cinchanchor. The suture is captured between the cinch lock and the cinchanchor.

A medical professional may deploy the cinch anchor within a patient bypressing the handle to overcome a threshold deployment force. The cinchmay be positioned into a working channel of an endoscope. The suturecapturing portion may be extended out of the working channel of anendoscope. In various embodiments, the patient may be stitched with asuture. The suture capturing portion of the cinch lock may be used tocapture the suture. In some embodiments, the suture capturing portionmay include a hook. The cinch lock may then be retracted into the anchorhousing. The medical professional may manipulate a handle to control thecinch lock and the capturing of the suture. In various embodiments, thesuture is cinched by an interference fit between the cinch anchor andthe cinch lock.

In accordance with another embodiment, a cinching system includes anendoscope having an insertion tube. The insertion tube has at least oneworking channel. A cinching device includes a handle movably coupledwith a flexible drive wire. The handle is configured to move the drivewire proximally or distally within a working channel of an endoscope.The cinching device includes a cinch lock having a suture capturingportion. The cinch lock is coupled with a distal end of the drive wire.The distal end of the drive wire may be flexible. The distal end of thewire may be pre-formed to a particular shape (e.g. curved, bent). Theseadvantageously allow the hook to capture the suture easily. Movement ofthe drive wire in a distal direction causes movement of the cinch lockin a distal direction. A cinch anchor is configured to receive the cinchlock and has a lumen through which the drive wire passes. An innerdiameter of the lumen is configured to provide an interference fit withthe cinch lock and suture when the cinch lock enters the lumen.

In accordance with yet another embodiment, a cinching device includes adelivery housing configured to fit within a working channel of anendoscope. A cinch anchor is coupled with the delivery housing. Thecinch anchor has a lumen extending from a proximal end to a distal end.A cinch lock has a suture capturing portion movably positioned in thelumen. The suture capturing portion is configured to capture a suture.The cinch lock is configured to provide an interference fit with aninner diameter formed by the lumen when the cinch lock and suture entersthe lumen.

In various embodiments, the suture capturing portion is rotatable. Tothat end, the suture capturing portion may be connected to a flexiblewire. In some embodiments, the flexible wire may have a pre-formedshaped (e.g., a non-linear shape).

Among other things, the cinch lock may have a break notch configured tobreak upon application of a threshold force. In various embodiments, thesuture capturing portion includes a hook. The suture capturing portionmay have an opening for receiving the suture. The opening may beproximally facing. However, in some other embodiments, the opening maybe facing radially outwardly.

BRIEF DESCRIPTION OF THE DRAWINGS

Those skilled in the art should more fully appreciate advantages ofvarious embodiments of the invention from the following “Description ofIllustrative Embodiments,” discussed with reference to the drawingssummarized immediately below.

FIG. 1 schematically shows a patient lying on a table in a hospitalenvironment in accordance with illustrative embodiments of theinvention.

FIG. 2A schematically shows an endoscope in accordance with illustrativeembodiments of the invention.

FIG. 2B schematically shows a partially exposed view of the insertiontube in accordance with illustrative embodiments.

FIG. 2C schematically shows the distal end of the insertion tube inaccordance with illustrative embodiments of the invention.

FIG. 3 schematically shows a cinching device in accordance withillustrative embodiments.

FIG. 4 shows a process of cinching a suture in accordance withillustrative embodiments of the invention.

FIGS. 5A-5B schematically show the delivery shaft advancing into theaccess port in accordance with illustrative embodiments of theinvention.

FIG. 5C schematically shows the suture capturing portion extended fromthe working channel in accordance with illustrative embodiments of theinvention.

FIG. 6A schematically shows a part of the suture capturing portionbeginning to extend from the delivery housing.

FIG. 6B schematically shows a cross-sectional view of the cinchdeployment system in accordance with illustrative embodiments.

FIG. 7A schematically shows the suture capturing portion capturing thesuture in accordance with illustrative embodiments of the invention.

FIGS. 7B-7E schematically show the captured suture being pulled into theworking channel of the insertion tube in accordance with illustrativeembodiments.

FIG. 8A schematically shows a cross-sectional view of the distal end ofthe cinch deployment system in accordance with illustrative embodimentsof the invention.

FIG. 8B schematically shows the cross-sectional view of FIG. 8A afterthe cinch lock is disengaged from the capture portion.

FIGS. 9A schematically shows a see-through view of the cinch anchor whenthe suture is retained by the cinch lock in accordance with illustrativeembodiments of the invention.

FIG. 9B schematically shows a cross-sectional view of the cinch anchorwhen the suture is retained by the cinch lock in accordance withillustrative embodiments of the invention.

FIGS. 10A-10D schematically show alternative configurations of the cinchin accordance with illustrative embodiments of the invention.

FIGS. 11-14 schematically show a process of capturing and locking thesuture to the anchor using the cinches shown in FIGS. 10A-10D,respectively.

FIG. 15A-15G schematically show an alternative embodiment of the suturecapturing portion in accordance with illustrative embodiments of theinvention.

FIG. 16 schematically shows a rotation feature of the cinching device inaccordance with illustrative embodiments of the invention.

FIGS. 17A-17F schematically show operation of the handle of the cinchingdevice in accordance with illustrative embodiments of the invention.

FIGS. 18A-18D schematically shows the cinch having a cinch lock with anintegrated suture capturing portion in accordance with illustrativeembodiments.

FIGS. 19A-19B schematically shows a cross-sectional view of the cinchanchor when the suture is retained by the cinch lock in accordance withillustrative embodiments of the invention.

FIG. 20 schematically shows that the wire may be pre-formed in aparticularly curved (or other) shape for easier suture capture inaccordance with illustrative embodiments of the invention.

FIGS. 21A-21B schematically show that in some embodiments, the proximalend of the cinch lock may be truncated/ open for easier suture capturingand visualization in accordance with illustrative embodiments of theinvention.

FIGS. 22A-22B schematically show the cinch lock having a break notch inaccordance with illustrative embodiments.

It should be noted that the foregoing figures and the elements depictedtherein are not necessarily drawn to consistent scale or to any scale.Unless the context otherwise suggests, like elements are indicated bylike numerals. The drawings are primarily for illustrative purposes andare not intended to limit the scope of the inventive subject matterdescribed herein.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

In illustrative embodiments, an endoscope has a flexible insertion tubewith a working channel through which a cinch extends to capture andcinch a suture. To that end, a cinching device is configured to deliverand deploy the cinch. The cinch deployment system includes a deliveryhousing coupled with a cinch anchor. The cinch anchor has a centrallumen extending therethrough. A snare (or other hooked wire) extends outof the lumen of the anchor and captures one or more free ends of thesuture. When the snare is retracted into the lumen of the anchor, alocking mechanism of the snare secures the suture to the anchor. Thelocking mechanism may then be disengaged from the snare, and the anchormay be disengaged from the delivery device and deployed within apatient. Accordingly, the anchor and the locking device may be used tocinch the sutures and the anchor may be left in the patient's body.Details of illustrative embodiments are discussed below.

In the currently available flexible endoscopy cinching devices known tothe inventors, the suture is loaded into the cinch outside the patient'sbody. Such devices often utilize a suture threader to thread the sutureinto a cinch, enabling the cinch to advance through a working channel ofthe endoscope. In contrast, illustrative embodiments capture the sutureinside the patient's body at the site of therapy (also referred to asthe tissue site or operation site), advantageously allowing moreflexibility to the medical practitioner with the usage of tools that donot pre-load the suture.

FIG. 1 schematically shows a patient 12 lying on a surgical table orexamination table in a hospital environment 10 in accordance withillustrative embodiments of the invention. The environment 10 may be,for example, within an endoscopy unit of the hospital. The endoscopyunit may include medical practitioners 14 (e.g., gastroenterologists orsurgeons), trained nurses 16, and a variety of medical devices. Forexample, the medical devices may include an endoscope 18, a videodisplay 20, and other equipment. Procedures performed within theendoscopy unit may include gastrointestinal endoscopy (such asgastroscopy, colonoscopy, ERCP, and endoscopic ultrasound),bronchoscopy, cystoscopy, or other more specialized procedures.

FIGS. 2A-2C schematically show an endoscope 18 in accordance withillustrative embodiments of the invention. As known by those in the art,flexible endoscopes 18 (e.g., colonoscope, gastroscope) are positionedinto the body of the patient 12 through the body's natural orifices(e.g., mouth, anus). To that end, the endoscope 18 has a long andflexible insertion tube 22 that is adjustable to the natural pathwayswithin the body. Furthermore, the endoscope 18 has a number of channelsrunning through the insertion tube 22. One of these channels is aworking channel, through which tools may be advanced to a distal end 23of the insertion tube 22.

The endoscope 18 may be contrasted with other devices such aslaparoscopes, which are not inserted into the patient's 12 naturalorifices. Instead, laparoscopes are inserted into one of the accessholes made in the patient 12 during a laparoscopic procedure. Usually,three access holes are made for laparoscopy procedures, one for therigid scope, and two ports for the tools such as forceps, scissor,suture, etc. Laparoscopes have a non-flexible, rigid, and shortinsertion tube that is sent through one of the access holes into thebody. Generally, laparoscopes do not have a working channel for runningtools therethrough. In contrast, the insertion tube 22 of the endoscope18 (colonoscope, gastroscope) is flexible to travel through the body'snatural orifices and has a working channel. Various embodiments may beused with a variety of scopes, such as laparoscopes. However, preferredembodiments are used with a flexible insertion tube 22.

The endoscope 18 has a control section 26 to help guide the insertiontube 22 through the patient's 12 bodily pathways (e.g., the winding GItract). To that end, the endoscope 18 includes control dials 26 thatallow control of the position and orientation of the insertion tube 22(e.g., bending of the distal end 23 up or down, and right or left). Likemany endoscopes, the endoscope 18 may have a plurality of imagingcontrols, such as an image freeze button and image capture button. Theremay also be control chromoendoscopy buttons that may change the color ofthe video in the display 20. The control section 24 may also include asuction button 28 and an air/water button 30. The endoscope 18 may beconnected to a light supply via a light guide 31, an air supply via anair supply connector 32, a water supply via a water supply connector 34,and a suction supply via a suction connector 36. Thus, light, air,water, and/or suction, may be delivered through the umbilical cord 35 tothe distal end 23 of the insertion tube 22 through the variousaforementioned channels.

Water, air, suction, and other functions may selectively be applied atthe distal end 23 via separate channels within the insertion tube 22.For example, the user may press the water button 30 to selectively spraywater out of the distal end 23. To that end, water is pulled from anexternal water supply through the water supply connector 34, passesthrough an umbilical cord 35 of the endoscope 18, and then goes down theinsertion tube 22 and out of the distal end 23. A similar process isfollowed for other functions, including light and suction. Each of thesefunctions may have a dedicated channel within the endoscope 18.

FIG. 2B schematically shows a partially exposed view of the insertiontube 22 in accordance with illustrative embodiments. The insertion tube22 has a plurality of channels 38-41 and wires 42-45 within theinsertion tube 22 that are configured to provide various utility to theendoscope 18. For example, the insertion tube 22 includes the biopsychannel 38, an air channel 39, a water channel 40, and a water jetchannel 41. The insertion tube 22 may also include light guide fibers42, a wire for adjustable stiffness 43, angulation wires 44, and CCDsignal wires 45, among other things. These channels 38-41 and wires42-45 are within a housing of the insertion tube 22. The housing of theinsertion tube 22 may include an out outer polymer top coat and baselayer 46. Underneath the polymer top coat 46 may be a stainless steelwire mesh 47, along with an outer spiral metal band 48 an inner spiralmetal bands 49.

FIG. 2C schematically shows the distal end 23 of the insertion tube 22with a tool 50 extending out of the working channel 38 in accordancewith illustrative embodiments of the invention. The tool 50 may bepositioned in the working channel 38 by passing through an accessoryport 37 (shown in FIG. 2A). For example, FIG. 2C schematically shows abiopsy forceps 50 extending out of the working channel 38. Variousembodiments use a cinching delivery device 54 to deliver a cinch via theworking channel 38.

FIG. 3 schematically shows a cinching device 54 in accordance withillustrative embodiments. The cinching device 54 includes a handleslider 56 with openings configured to receive the practitioner's 14thumb fingers. During use, the handle slider 56 slides along a handleframe 58. Movement of the handle slider 56 relative to the handle frame58 causes a drive wire inside delivery shaft 74 to move proximally ordistally along the delivery shaft 74. In various embodiments, the drivewire 60 (also referred to as a pull wire 60) may be movable in an axialdirection (e.g., along A1) within a delivery shaft 74. The drive wire 60may be a long pull wire such as a Bowden cable, which is inside a Bowdencoil 65 for support. The Bowden coil (or spring guide) supports the pullwire 60. The pull wire 60 has a small diameter and generally does nothave a structural support on its own. The pull wire 60 may be flexible.The pull wire 60 may also be pre-formed into a given shape (e.g., biasedto the particular shape and/or non-linear shape). In variousembodiments, the Bowden coil 65 provides the structural support to thepull wire 60 (while going through working channel, etc.). It should beunderstood that although A1 is shown as a straight axis, that in variousembodiments, the delivery shaft is configured to bend and/or twist in amanner similar to the insertion tube 22. Therefore, moving along theaxis A1 may not be straight line axial movement.

The suture cinching device 54 includes a cinch deployment system 62configured to deploy the cinch 64. The cinch 64 is configured to cinchone or more sutures that have been threaded within the patient 12 (e.g.,within the patient's GI tract). The cinch 64 includes a cinch lock 66, asuture capturing portion 68 (e.g., a snare or a wire), and a cinchanchor 70. The cinch anchor 70 sits within a delivery housing 72 at adistal end of the delivery shaft 74. In some embodiments, the firstanchor fastener 83 is configured to couple the anchor 70 to the deliveryhousing 72. In some embodiments, the cinch anchor 70 includes an anchorfastener 83 (see FIG. 6A) configured to couple the cinch anchor 70 withthe delivery housing 72. To that end, the delivery housing 72 mayinclude a counterpart anchor fastener in the delivery housing 72. Insome embodiments, the first anchor fastener 83 is configured topermanently couple to a second anchor fastener in the delivery housing72. In some embodiments, the first anchor fastener 83 is configured toremovably couple with the counterpart anchor fastener 113 in thedelivery housing 72. For example, the first anchor fastener 83 mayinclude a circular protrusion and the second anchor fastener may be acavity configured to receive the protrusion. The circular protrusion maysnap into the cavity by deforming, or by deforming a portion of thecircumference of the cavity. Alternatively, the first anchor fastener83, and/or the counterpart second anchor fastener may include a snap, ahook, a weld, an adhesive, a thread, a pin, or any combination thereof.However, in some embodiments, the cinch anchor 70 and the deliveryhousing 72 may be formed as a single component.

FIG. 4 shows a process 400 of cinching a suture in accordance withillustrative embodiments of the invention. It should be noted that thisprocess is simplified from a longer process that normally would be usedto cinch the suture. Accordingly, the process 400 of cinching the suturelikely has many steps that those skilled in the art likely would use. Inaddition, some of the steps may be performed in a different order thanthat shown. Additionally, or alternatively, some of the steps may beperformed at the same time. Those skilled in the art therefore canmodify the process 400 as appropriate.

The process 400 begins at step 402, where the medical practitioner 14sutures a perforation inside of the patient 12. The process of suturinga perforation is known in the art and therefore is not described ingreat detail. In general, the process involves grasping tissue near theperforation (e.g., using a tissue grasping tool 50), retracting thetissue, driving a needle coupled to the suture through the tissue, andrepeating the stitches as desired. Thus, in the above described example,the suture has two ends: a first end coupled with the needle, and asecond free end. Various embodiments may cinch the free end of thesuture and/or the first end coupled with the needle together orseparately. In some other embodiments, the suture is coupled to a needlethat is part of a needle assembly (e.g., that passes through the tissueand grips the tissue). The suture may thus be considered to have asingle free end, and a second anchored end. Accordingly, someembodiments may cinch just a single end of the suture. However, someother embodiments may cinch a plurality of locations along the suture(e.g., both ends of one or more sutures). The suture may be formed ofany materials commonly used for surgical suture, such as stainlesssteel, nitinol, nylon, braided polyester, polypropylene, and/or silk.

The process proceeds to step 404, which provides the endoscopic suturecinching device 54. The device 54 may be provided to the medicalpractitioner 14 during and/or after a medical procedure, such as apolypectomy. During the medical procedure, the medical practitioner 14may take a biopsy from the patient 12 by using the biopsy tool 50 (e.g.,biopsy forceps) to remove a polyp. The biopsy tool 50 may be placedwithin the working channel 38 of the endoscope 18. The medicalpractitioner 14 may then use any suturing tool to suture theperforation. In various embodiments, the suturing tool may be attachedto the outside of the distal end 23 of the insertion tube 22. Variousembodiments of the endoscope 18 may include one or more working channels38.

Illustrative embodiments work with a variety of sutures and/orendoscopic suturing devices. For example, illustrative embodimentsadvantageously do not require pre-loading the suture into the suturecinching device 54, or passing the suture through the accessory port 37of the endoscope 18. Advantageously, the suture cinching device 54 maybe used to cinch a suture that was previously applied to the patient 12(e.g., to a perforation) using an integrated or separate stitching tool.

The process proceeds to step 406, which positions the cinch deploymentsystem 62 into the working channel 38 of the endoscope 18. To that end,a distal end of the delivery shaft 74 may be positioned with the accessport 37 of the endoscope 18. FIGS. 5A-5B schematically show the deliveryshaft 74 advancing into the access port 37. The delivery shaft 74 may bedriven into the access port 37. As shown, the delivery shaft 74 mayadvantageously flex in a manner similar to the insertion tube 22. Itshould be further understood that the endoscope 18 and cinching device54 are not necessarily drawn to scale. However, various components areshown here for purposes of discussion.

At step 408, the process extends a suture capturing portion 68 from theworking channel of the endoscope 18. In various embodiments, extendingthe suture capturing portion 68 includes partially extending the suturecapturing portion (e.g., see FIGS. 18C-18D). Based on physician's 14technique and also how much space is available in the patient 12 body,the delivery housing 72 can also be fully extended out of the workingchannel 38, partially outside, or even inside of the working channel 38.FIG. 5C schematically shows the suture capturing portion 68 extendedfrom the working channel 38 in accordance with illustrative embodimentsof the invention. In FIG. 5C the suture capturing portion 68 is shown asa snare. However, some embodiments may include a hook and/or other shapeconfigured to capture the suture. In preferred embodiments, the suturecapturing portion 68, or portions thereof, are flexible. In variousembodiments, the suture capturing portion 68 may expand after or as itextends out of the delivery housing 72 and/or anchor 70. In variousembodiments, the suture capturing portion 68 defines an opening 79 thatis larger than the diameter of the lumen 73. This advantageously allowsthe snare/hook to capture the suture 78 easily. Because of theflexibility, the snare/hook (capturing portion) can be retracted intothe delivery catheter (e.g., delivery housing 72) and/or the anchor 70.

To that end, the suture capturing portion 68 may be formed from a wire.For example, the suture capturing portion 68 may be a thin nitinol orstainless-steel wire. The capturing portion 68 (e.g., the wire) may havea thickness of between about 0.005 inch to about 0.025 inch. Among othershapes, the capturing portion 68 may have a circular, rectangular,square, elliptical, or hexagonal, cross-section. The capturing portioncan be formed from, among other things, solid wire, multi-stranded wire,stamped material, injection molded plastic such as PEEK, polycarbonate,polypropylene, and/or ABS. However, the suture capturing portion 68 maytake a variety of forms. For example, the suture capturing portion andthe suture may be magnetically attractive to one another. Alternatively,the suture capturing portion may have an adhesive configured to graspthe suture.

In various embodiments, the capturing portion 68 may be formed as asnare or loop that is biased towards an open configuration (e.g., openposition shown in FIG. 5C). FIG. 6A schematically shows a part of thesuture capturing portion 68 beginning to extend from the deliveryhousing 72. In this view, the insertion tube 22 is omitted for clarity.However, it should be understood that the delivery housing 72 ispositioned within the working channel 38 of the insertion tube 22 (e.g.,see FIG. 2C). As shown, when the loop is in the delivery housing 72, thedelivery housing 72 presses the loop into the closed position.

FIG. 6B schematically shows a cross-sectional view of the cinchdeployment system 62 in accordance with illustrative embodiments. Asshown, the suture capturing portion 68 is extended further than shown inFIG. 6A. The cinch anchor 70 has a lumen 73 through which the suturingcapturing portion 68 extends. To that end, the suture capturing portion68 may be extended out of the working channel 38 by the medicalpractitioner 14 pressing the handle frame 58, which is coupled with aproximal end of the drive wire 60. As the drive wire 60 is pressed, thesuture capturing portion 68 is advanced and extended out of the lumen 73of the anchor 70.

In various embodiments, the suture capturing portion is coupled with thecinch lock 66. The cinch lock 66 is configured to retain the capturedsuture within the cinch anchor 70. To that end, an inner diameter of thelumen 73 may be configured to provide an interference fit with the cinchlock 66 and suture 78. Specifically, the suture becomes trapped betweenthe cinch lock 66 and the cinch anchor 70 when the suture capturingportion 68 is fully retracted into the cinch anchor 70. The cinch anchor70 may also have a counterpart shoulder 76 which prevents the cinch lock66 from being retracted further into the working channel 38, as will bedescribed in more detail later. The cinch lock 66 may have across-sectional shape of a rectangle, square, a circle, a triangle, adiamond, or any combination thereof.

After the suture capturing portion 68 is extended, the suture iscaptured at step 410. FIG. 7A schematically shows the suture capturingportion 68 capturing the suture 78 in accordance with illustrativeembodiments of the invention. The suture 78 may be passed through anopening 79 of the suture capturing portion 68, as shown in FIG. 7A.Alternatively, the suture capturing portion 68 may be positioned over afree end of the suture 78. In some other embodiments, the suture 78 maybe hooked, clipped, wound, or otherwise retained the suture capturingportion 68. Furthermore, various embodiments may capture use a tool 50to assist with capturing the suture 78. For example, a needle, a clamp,and/or a forceps, may be used to help the capturing portion 68 capturethe suture 78.

The process then proceeds to step 412, which retracts the suturecapturing portion 68 into the cinch anchor 70 to cinch the suture 78.FIGS. 7B-7E schematically show the captured suture 78 being pulled intothe anchor 70 in accordance with illustrative embodiments. As shown inFIG. 7B, the delivery housing 72 may be positioned within the workingchannel 38 (shown in broken lines) of the insertion tube 22. However, asshown in FIG. 7C, the delivery housing 72 may be extended out of theworking channel 38. Thus, in some embodiments, the suture 78 may beretracted into the cinch anchor 70 and/or delivery housing 72, which mayor may not be inside of or extended from the working channel 38. Themedical practitioner 14 pulls the handle frame 58 to retract the drivewire 60. Drive wire 60 is coupled with the suture capturing portion 68,and thus, as the drive wire 60 is retracted, the suture capturingportion 68 is also retracted. Because the suture capturing portion 68has captured the suture 78, the suture 78 is also pulled towards thedelivery housing 72 and the anchor 70. Eventually, as shown in FIG. 7E,the suture 78 is pulled into the anchor 70. Furthermore, the cinch lock66 is also pulled into the cinch anchor 70. In various embodiments, thesuture 78 is tensioned by pulling back the suture 78 or insertion tube22 and then bringing the delivery housing 72 closer to the tissue at theincision site to ensure that the cinch is tight.

FIG. 8A schematically shows a cross-sectional view of the distal end ofthe cinch deployment system 62 in accordance with illustrativeembodiments of the invention. As shown, the suture capturing portion 68and the cinch lock 66 have been retracted into the cinch anchor 70. Thecinch lock 66 comes to rest against a shoulder 76 formed by the innerdiameter of the lumen 73. Additionally, or alternatively, the innerdiameter of the lumen may be tapered. The medical practitioner 14 pullssufficiently tight on the handle frame 58, such that the suture 78 iswedged between the cinch lock 66 and the cinch anchor 70. Accordingly,the suture 78 is cinched by the cinch mechanism.

The process then proceeds to step 414, which disengages the cinch lock66 from the capture portion 68. FIG. 8B schematically shows thecross-sectional view of FIG. 8A after the cinch lock 66 is disengagedfrom the capture portion 68. The medical practitioner 14 may pull on thedrive wire 60 coupled with the capture portion 68. The capture portion68 and the cinch lock 66 are configured so that the capture portion 68uncouples after a threshold amount of force is met. Thus, the suturecapturing portion 68 may be removed from the patient 12.

The process then proceeds to step 416, which deploys the cinched suture78. Specifically, the cinch anchor 70, which is now coupled with thecinch lock 66 and the suture 78 is deployed. The medical practitionermay press the drive wire 60 (before or after uncoupling the suturecapturing portion 68 from the drive wire 60) against the cinch anchor 70and/or the cinch lock 66. In some embodiments, the broken/ disengagedcapture portion 6 may be positioned between the drive wire 60 and thecinch anchor 70 and/or cinch lock 66. Regardless, illustrativeembodiments may consider the drive wire 60 to be “pressing” against thecinch anchor 70 and/or the cinch lock 66 when deploying the cinch anchor70, even if the broken snare wire 68 is physically between the drivewire 60 and the anchor 70 or lock 66. After a threshold force is met,the cinch anchor 70 is dislodged from the delivery housing 72 andremains in the patient 12.

FIGS. 9A schematically shows a see-through view of the cinch anchor 70when the suture 78 is retained by the cinch lock 66 in accordance withillustrative embodiments of the invention. FIG. 9B schematically shows across-sectional view of the cinch anchor 70 when the suture 78 isretained by the cinch lock 66 in accordance with illustrativeembodiments of the invention. As shown, an interference fit 80 iscreated by the cinch lock 66, the suture 78, and the inner diameter ofthe cinch anchor 70. The interference fit 80 squeezes the suture 78therein, forming a crimp, and retains the suture 78 to the sutureanchor. Accordingly, the suture 78 is now cinched.

The process proceeds to step 418, which asks if there are more suturesto cinch? If yes, then the process returns to step 404, which providingthe endoscopic suture cinching device (e.g., with a cinch lock 66engaged with the suture capturing portion 68). In some embodiments, thesuture cinching device is removed from the working channel 38 and anendoscopic scissor may be used to cut the suture 78. The process is thenrepeated substantially as described above until the suture 78 and/oradditional sutures 78 are cinched. In some embodiments, both ends of thesuture 78 are cinched one at a time. In some other embodiments, bothends of the suture 78 may be cinched using a single anchor 70, capturingportion 68, and cinch lock 66. When there are no more sutures 78 tocinch, the process comes to an end.

It should be apparent to one skilled in the art that illustrativeembodiments provide a number of advantages to medical practitioners 14and the patient 12. Specifically, illustrative embodimentsadvantageously enable cinching the suture 78 at any place along thelength of the suture 78 inside the patient 12 body. Illustrativeembodiments can cinch the suture 78 as many times as needed.Furthermore, illustrative embodiments advantageously reduce the stepsthat medical practitioner takes to perform the suturing process.Illustrative embodiments advantageously enable suturing with or withoutpre-loading the suture 78 into the cinch outside of the patient's body.Furthermore, illustrative embodiments enable the use of a short suture,such that the free end of the suture does not come outside of thepatient's body. The suture may be 1 inch to 10 inches, for example.Accordingly, illustrative embodiments may operate with a short or a longbecause the cinch does not need to be loaded into the cinch at theproximal side of the working channel.

FIGS. 10A-10D schematically show alternative configurations of the cinch64 in accordance with illustrative embodiments of the invention. Forexample, FIG. 10A schematically shows an exemplary hook suture capturingportion 68. The hook may be formed from a snare wire 68, and may includea first snare wire 68A, a second snare wire 68B, and a third snare wire68C. In some embodiments, the third snare wire 68C may be normallyclosed, but may be biased open by a portion of the anchor 70.

FIG. 10B schematically shows an exemplary ball-snare suture capturingportion 68. The lock 66 is shown as a ball crimp configured to wraparound the suture 78 to capture the suture 78. FIG. 10C schematicallyshows an exemplary wrap snare suture capturing portion 68. The lock 66may be a crimp configured to wrap around the suture 78 to capture thesuture 78. FIG. 10D schematically shows the suture capturing portion 68as an exemplary pronged snare 500. The lock 66 is a pronged crimp 130Bconfigured to capture the suture 68. In some embodiments, as shown, thepronged crimp 130B may include 2 prongs. Alternatively, in someembodiments, the pronged crimp 130B may comprise one or more prongs(e.g., 4-prongs separated by 90 degrees of rotation). In someembodiments, the anchor 70 may include a prong crimp cavity 114 toaccept at least a portion of the pronged crimp 130B.

FIGS. 11-14 schematically show a process of capturing and locking thesuture 78 to the anchor 70 using the various cinches 64 shown in FIGS.10A-10D, respectively. As shown in FIG. 14 , in some embodiments, thesuture capturing portion may be integrated with the cinch lock 66 and/orextend beyond the cinch lock 66.

FIG. 15A-15G schematically show an alternative embodiment of the suturecapturing portion 68 in accordance with illustrative embodiments of theinvention. As shown in FIG. 15A, the suture capturing portion 68 may bean extended and bent wire. In various embodiments, the suture capturingportion 68 may be formed to bias towards a bent configuration when notcompressed. The capturing portion 68 may be flexible and/or resilient.While the capturing portion 68 is inside the delivery housing 72, amaximum dimension D3 in a direction perpendicular to the axis A1 issmaller than a diameter D1 of the delivery housing 72 and a diameter D2of the lumen 73. However, when the capturing portion 68 is outside thedelivery housing 72 and/or the anchor 70, the resilient portion 68returns to its normal bent configuration. This normal configuration mayhave the maximum dimension D3 greater than the diameter D1 of thehousing 72 or the diameter D2 of the lumen 73.

FIG. 15B schematically shows the snare wire 68 fully extended. The wire68 may form the opening 79 configured to hook the suture 78 and guide ittowards the cinch lock 66. FIGS. 15C-15E schematically shows a rotatedsuture capturing portion 68 with the suture 78 captured being graduallyretracted into the housing 72.

FIG. 15F schematically shows a transparent view of the delivery housing72 of FIGS. 15A-15E. The cinch lock 66 is retracted and settled into thelumen 73 of the anchor 70. As shown, the maximum dimension D3 of thesuture capturing portion 68 is smaller than the diameter D1 of thedelivery housing 72 and the dimeter D2 of the lumen 73 (particularly thediameter D2 of the lumen 73 at the point where the cinch lock 66 andsuture 78 form an interference fit with the lumen 73, such as theshoulder 76). It should also be understood from FIGS. 15A and 15F that,in various embodiments, the capturing portion 68 dimension D3 may expandto greater than a diameter of the lock 66 when extended. Similarly, thecapturing portion 68 dimension D3 may return to smaller than a diameterof the lock 66 when retracted.

FIG. 15G schematically shows a cut-open view of the delivery housing 72of FIGS. 15A-15E after the snare wire 68 is disengaged from the lockingmechanism. Snare wire 68 disengages from crimp formed by lock 66 whenpulling the pull wire 60 with the handle slide 56. The crimp and shortwire 68 of the hook may remain in the anchor 70, while the suture 78 isjammed and deformed between the snare crimp formed by the lock 66 andanchor housing 70.

FIG. 16 schematically show a rotation feature of the cinching device 54in accordance with illustrative embodiments of the invention. Asdescribed previously, the cinching device 54 may be coupled with theendoscope 18. In illustrative embodiments, the handle 51 may be rotated(e.g., with respect to the coupler 61) to rotate the cinch 64. As shown,the coupler 61 does not rotate. In some embodiments, the coupler 61 maycouple with the accessory port 37. However, in some other embodiments,the coupler 61 does not couple with the accessory port 37. The coupler61 maintains its orientation (e.g., relative to the endoscope 18) as thehandle 51 and the cinch 64 rotate (as well as the rod 60). Accordingly,the capture portion 68 is advantageously rotatable to allow easy captureof the suture 78. For example, the rotation allows repositioning theloop of the snare or the direction of the hook to an ideal location tocapture the suture 78. To that end, in various embodiments, the pullwire 60 is attached to the handle slider 56, and the outer coil 65(shown in FIG. 6B) is attached to the coupler 61. This allows relativerotation of the drive wire 60, and thus the cinch 64, relative to theflexible tubing 22 and the coil 65.

In various embodiments, the handle 51 is outside of the working channel38 and is manipulated by the medical practitioner 14. To go through theworking channel 38, the delivery shaft is preferably long for endoscopicprocedures (e.g., about 150 cm to about 250 cm).

FIGS. 17A-17F schematically show operation of the handle of the cinchingdevice 54 in accordance with illustrative embodiments of the invention.FIG. 17A schematically shows that the capture portion 68 is inside thedelivery housing 72. FIG. 17B shows the handle slider 56 fullydepressed, and the capture portion 68 extending out of the deliveryhousing 72. FIG. 17C schematically shows the suture 78 captured. Forexample, in the case of a snare, illustrative embodiments use the needleto pass the suture 78 through the snare 68. In the case of snare hook,illustrative embodiments use the hook 68 to capture the suture 78.Although not shown, the handle 51 may be rotated to assist withcapturing the suture 78.

FIGS. 17D schematically show that the capturing portion 68 is partiallyretracted inside the delivery housing 72 to begin bringing the suture 78inside the anchor 70. As shown, the handle slider 56 is partiallyretracted to partially retract the capturing portion 68. FIGS. 17Eschematically shows the handle slider 56 retracted further. The suture78 is thus jammed between the crimp and the anchor 70. As the pull wire60 is pulled further, the snare wires or a portion thereof are uncoupled(e.g., broken away) from the crimp. FIGS. 17F schematically shows thecinch lock 66 being deployed by pressing the handle slider 56 again tocause the drive wire 60 to deposit the anchor 70.

FIGS. 18A-18D schematically shows the cinch 64 having the cinch lock 66with an integrated suture capturing portion 68 in accordance withillustrative embodiments. As shown, the cinch lock 66 includes thesuture capturing portion 68. Thus, various embodiments may not have aseparate suture capturing portion 68, such as a wire. Instead, the lock66 may be coupled directly with the pull wire 60.

In various embodiments, the suture capturing portion 68 may be a hook,e.g., a rigid hook (as opposed to a flexible wire or snare). To thatend, the suture capturing portion 68 may include a proximal opening 82,a distal capturing portion 84 positioned distally of the proximalopening 82, and a suture opening 86. In various embodiments, theproximal opening 82 may face radially outwardly, as in FIG. 18A, orproximally towards the medical practitioner. Thus, the medicalpractitioner may conveniently capture the suture 78 by positioning thesuture 78 through the proximal opening 82 and pulling the cinch lock 66proximally, as shown in FIG. 18B. The distal capturing portion 84, orcapturing hook 84, is configured to prevent the suture 78 from escapingor dislodging from the cinch suture capturing portion 68 when tension isapplied on the suture 78 (e.g., by exiting again through the proximalopening 82). The suture 78 may pass through the suture opening 86 of thecinch lock 66 when captured.

The suture capturing portion 68 and/or the entire cinch lock 66 may beformed from metals (stainless steel, brass, etc.), and/or plastic (PEEK,PP, etc.). If formed from metal, the cinch lock 66 can be manufacturedby laser cutting hypotube, machining, stamping, etc. If the cinch lock66 is formed from plastic, it can be manufactured by machining,injection molding, etc.

FIGS. 18C-18D schematically show partially extending the suturecapturing portion 68 to capture the suture 78 in accordance withillustrative embodiments. As shown, the suture capturing portion 68 ispartially extending from the cinch anchor 72 (which itself is within thedelivery housing, not shown). Partially exposing the opening 82 allowsthe suture 78 to be captured by the suture capturing portion 68, asshown in FIG. 18D. Thus, in various embodiments, the wire 60 does notneed to leave lumen 67 to capture the suture 78.

FIGS. 19A-19B schematically show a cross-sectional view of the cinchanchor 72 when the suture 78 is retained by the cinch lock 66 inaccordance with illustrative embodiments of the invention. FIG. 19Ashows the captured suture 78 with the cinch 64 in an undeployedconfiguration. FIG. 19B shows the captured suture 78 with the cinch 64in the deployed configuration. In various embodiments, the wire 60 isattached to the cinch lock 66 by: crimp, weld, glue, magnet, etc. Thecinch lock 66 may have a wire receiving lumen 67 in which the wire 60 ispositioned. However, some other embodiments may attach the end of thelock 66 to the wire (e.g., see FIG. 21B). To transition to the deployedconfiguration, the wire 60 is disconnected from the cinch lock 66 (e.g.,by the user applying a threshold force to break the wire 60 from abreakable joint). For example, the wire 60 is disengaged from thecoupling crimp, weld, glue, press fit, etc. when a threshold of force isovercome. It should be understood that although the wire 60 isuncoupled/disconnected from the cinch lock 66, that some left-overportion of the wire 60 may remain coupled with the cinch lock 66. Asshown in FIG. 19B, the suture 70 is cinched between the anchor 72 andthe capturing hook (e.g., from the suture openings 86 of the lock 66through which the suture 78 passes).

FIG. 20 schematically shows that the wire 60 may be pre-formed in aparticularly curved (or other) shape for easier suture 78 capture. Invarious embodiments, pre-forming the wire 60 provides a particularorientation to the suture capturing portion 68. In various embodiments,the opening 82 may be angled differently. The wire 60 does not need toleave the anchor 72 to capture the suture 78. Furthermore, the medicalprofessional may rotate the wire 60, and thereby the proximal opening82, to assist in capturing the suture 78. After the suture 78 iscaptured, the medical professional may rotate the wire 60 again toadjust the orientation of the suture opening 86.

FIGS. 21A-21B schematically show that in some embodiments, a proximalend 88 of the cinch lock 66 may be truncated/exposed for easier suturecapturing and visualization by the medical professional. Accordingly, adistal portion of the wire 60 may be at least partially exposed. Byreducing the thickness or amount of material of lock at the proximal end88, it is advantageously easier for the suture 78 to enter the proximalopening 82. In some embodiments, the proximal opening 82 advantageouslybecomes larger. In various embodiments, the cinch lock 66 is configuredto disengage from the wire 60 at a breakable joint. The breakable jointis a weakened point configured to break upon application of sufficientforce (e.g., by the medical practitioner pulling on the wire 60 aftercinching the suture 78). The breakable joint may include a breakableweld, a breakable glue, breakable press fit, and/or a breakable crimp.

FIGS. 22A-22B schematically show the cinch lock 66 having a break notch90 in accordance with illustrative embodiments. The break notch 90 is aweakened point configured to break upon application of sufficient force(e.g., by the medical practitioner pulling on the wire 60 after cinchingthe suture 78). The break notch 90 may be a weakened portion of thecinch lock 60, or may be formed from a different material. The breaknotch 90 is configured to fail/break after the suture 78 is lockedbetween the cinch lock 66 and anchor 72 when pressure is applied by amedical practitioner to cinch the suture 78 (e.g., between the anchor).The cinch lock 66 is configured to disengage from the wire 60 at aweakened point (such as a notch) in the cinch lock 66. The hook is thusdisengaged from the wire 60. Additionally, the remaining part of thecinch lock 66 beneath the notch 90 is also uncoupled from the remainderof the cinch lock 66.

While various inventive embodiments have been described and illustratedherein, those of ordinary skill in the art will readily envision avariety of other means and/or structures for performing the functionand/or obtaining the results and/or one or more of the advantagesdescribed herein, and each of such variations and/or modifications isdeemed to be within the scope of the inventive embodiments describedherein. More generally, those skilled in the art will readily appreciatethat all parameters, dimensions, materials, and configurations describedherein are meant to be exemplary and that the actual parameters,dimensions, materials, and/or configurations will depend upon thespecific application or applications for which the inventive teachingsis/are used. Those skilled in the art will recognize, or be able toascertain using no more than routine experimentation, many equivalentsto the specific inventive embodiments described herein. It is,therefore, to be understood that the foregoing embodiments are presentedby way of example only and that, within the scope of the appended claimsand equivalents thereto, inventive embodiments may be practicedotherwise than as specifically described and claimed. Inventiveembodiments of the present disclosure are directed to each individualfeature, system, article, material, kit, and/or method described herein.In addition, any combination of two or more such features, systems,articles, materials, kits, and/or methods, if such features, systems,articles, materials, kits, and/or methods are not mutually inconsistent,is included within the inventive scope of the present disclosure.

Various inventive concepts may be embodied as one or more methods, ofwhich examples have been provided. The acts performed as part of themethod may be ordered in any suitable way. Accordingly, embodiments maybe constructed in which acts are performed in an order different thanillustrated, which may include performing some acts simultaneously, eventhough shown as sequential acts in illustrative embodiments.

Although the above discussion discloses various exemplary embodiments ofthe invention, it should be apparent that those skilled in the art canmake various modifications that will achieve some of the advantages ofthe invention without departing from the true scope of the invention.

What is claimed is:
 1. A method of cinching a suture, the methodcomprising: providing a cinch lock comprising a suture capturing portionconfigured to capture a suture, extending the suture capturing portionout of a lumen of a cinch anchor to capture the suture; retracting thesuture capturing portion into the lumen of the cinch anchor; andcinching the suture between the cinch lock and the cinch anchor.
 2. Themethod as defined by claim 1, further comprising: deploying the cinchanchor within a patient by pressing the handle to overcome a thresholddeployment force.
 3. The method as defined by claim 1, furthercomprising: positioning the cinch into working channel of an endoscope;and extending the suture capturing portion out of the working channel ofthe endoscope.
 4. The method as defined by claim 1, further comprisingrepeating cinching the suture between a second cinch lock and a secondcinch anchor at different locations on the suture.
 5. The method asdefined by claim 1, wherein the suture capturing portion includes ahook.
 6. The method as defined by claim 1, further comprising: stitchingthe suture in the patient prior to capturing the suture.
 7. The methodas defined by claim 1, wherein the suture is cinched by an interferencefit between the cinch anchor and the cinch lock.
 8. The method asdefined by claim 1, wherein the cinch lock has a suture openingconfigured to receive the suture.
 9. The method as defined by claim 1,wherein the suture lock has a break notch, the method further comprisingpulling the wire to position the suture lock into the suture anchor andovercome a threshold force to break the break notch.
 10. A cinchingsystem comprising: an endoscope having an insertion tube, the insertiontube having at least one working channel; a cinching device comprising:a handle movably coupled with a flexible drive wire, the handleconfigured to move the drive wire proximally or distally within aworking channel of an endoscope; a cinch lock having a suture capturingportion, the cinch lock coupled with a distal end of the drive wire,wherein movement of the drive wire in a distal direction causes movementof the cinch lock in a distal direction; a cinch anchor configured toreceive the cinch lock and having a lumen through which the drive wirepasses; wherein an inner diameter of the lumen is configured to providean interference fit with the cinch lock and suture when the cinch lockand suture enter the lumen.
 11. The system of claim 10, wherein thecinch lock is configured to detach from the flexible drive wire using abreakable joint.
 12. The system of claim 10, wherein the suturecapturing portion includes a hook.
 13. The system of claim 10, whereinthe suture capturing portion has an opening for receiving a suture. 14.The system of claim 13, wherein the opening is proximally facing. 15.The system of claim 13, wherein the opening faces radially outwardlyrelative to a central axis of the cinch lock.
 16. The system of claim10, wherein the suture capturing portion is rotatable.
 17. The system ofclaim 10, wherein the suture capturing portion is connected to aflexible wire.
 18. The system of claim 10, wherein the suture capturingportion is connected to a pre-shaped wire.
 19. A cinching devicecomprising: a delivery housing configured to fit within a workingchannel of an endoscope; a cinch anchor coupled with the deliveryhousing, the cinch anchor having a lumen extending from a proximal endto a distal end; a cinch lock having a suture capturing portion movablypositioned in the lumen, the suture capturing portion configured tocapture a suture, wherein the cinch lock is configured to provide aninterference fit with an inner diameter formed by the lumen when thecinch lock and suture enters the lumen.
 20. The cinching device of claim19, wherein the cinch lock includes a hook.